Introducer Sheath Assembly with Hub and Method of Joining a Hub to a Sheath Tube

Abstract

A tearaway introducer sheath assembly (10) for use in implantation of a catheter into a patient, having an elongated polytetrafluoroethylene sheath tube (12) and a proximal polyethylene hub component (16). The hub comprises two halves (22) insert molded about the sheath tube proximal end and joined to each other by frangible webs (28) enabling manual splitting. At least one pair of opposed holes (42) is formed through the tube proximal end portion 44, and a polyethylene liner (46) is inserted into the tube's proximal end portion. The polyethylene flows into the at least one pair of holes (42) to fuse with the liner, establishing a pair of physical joints (50′) integrally joining the liner (46) to a respective hub half (22). Upon manual splitting of the hub halves, the sheath tube easily splits along its length as a result of a property of the polytetrafluoroethylene material.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority from U.S. Provisional Patent Application Ser. No. 61 / 062,714, filed Jan. 29, 2008.FIELD OF THE INVENTION[0002]This relates to the field of medical devices, and more particularly to flexible medical tubing and components affixed thereto.BACKGROUND OF THE INVENTION[0003]Catheters are often used for the delivery and withdrawal of fluids to and from a blood vessel in a patient, respectively. The fluids may be medication that is administered to the patient, or blood that is withdrawn from the patient. The catheter may also be used for hemodialysis, in which blood is withdrawn from the patient, purified and returned simultaneously through respective lumens of the catheter, and much of the catheter remains within the patient's vasculature for an extended period of time for repeated treatments.[0004]Typically, to insert a catheter into a blood vessel, the blood vessel is located by known methods. An aspirating nee...

AI Technical Summary

Benefits of technology

[0011]In one practical embodiment, the method provides an assured joint of an introducer sheath tube of polytetrafluoroethylene (PTFE) and a liner and a hub component (or components) of a different plastic such as polyethylene.

[0013]An introducer assembly of the present invention may be made using the present inventive method where the hub component is molded to the sheath tube proximal end, where the hub comprises two halves initially joined to each other at frangible seams along opposite sides of the sheath tube, such that the hub component can be easily split for easy removal of the introducer sheath assembly from a catheter after insertion into a patient. The sheath tube has at least one pair of holes adjacent the proximal end through which the hub halves are formed with joints extending through the sheath tube holes affixing them to a liner within the sheath tube, so that each hub half remains assuredly affixed to a respective side of the sheath tube. Also, preferably, the liner includes a proximal end portion protruding beyond the sheath tube proximal end to which the hub component integrally joins, as well, and may include notches into the proximal end to initiate eventual sheath assembly splitting. The introducer sheath tube has inherent lines of weakness, and additionally may have slits partially therealong, to continue the splitting entirely along the sheath tube, resulting from the PTFE material. Other sheath tube materials may be used but scoring of an opposed pair of seams therealong would expected to be provided to facilitate sheath tube splitting.

Problems solved by technology

The introducer sheath tube has inherent lines of weakness, and additionally may have slits partially therealong, to continue the splitting entirely along the sheath tube, resulting from the PTFE material.

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